Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies

Dementia with Lewy bodies (DLB) is a neurodegenerative disease diagnosed primarily based on the presence of cognitive decline, which may include difficulties with memory, attention, and more. Additionally, at least two of the following symptoms are needed for a probable diagnosis of DLB, and at least one for a possible DLB diagnosis (McKeith et al. 2017 and 2020): * Fluctuations in cognition, attention, and/or alertness * Visual hallucinations * Spontaneous parkinsonism * REM sleep behavior disorder Patients with DLB can experience cognitive deficits that can fluctuate and can vary for each patient. These may include deficits in memory, executive functions (planning and organizing), attention, visual processing, and language. This study aims to evaluate the effect of red-light therapy, delivered using a helmet that contains small LED lights, in patients with DLB. Participants' cognitive functions, clinical symptoms, quality of life and functional cerebral connectivity will be evaluated before starting therapy and again after three and six months of twice daily therapy use. As DLB also indirectly affects caregivers, the caregiver's quality of life and burden will also be evaluated before and at three and six months of therapy use by the participant. The study's inclusion period is 24 months and the duration of participation for each patient is 8 months (+/-10 days) maximum.

NCT Number	NCT07602296
Lead Sponsor	University Hospital, Strasbourg, France
Conditions	Photobiomodulation, Dementia With Lewy Bodies
Enrollment	40 participants
Start Date	2026-06
Primary Completion	2028-12 (estimated)
Study Completion	2029-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-23